Study of Iguratimod in Sjögren's Syndrome

A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome

Sponsoren

Hauptsponsor: Peking Union Medical College Hospital

Quelle Peking Union Medical College Hospital
Kurze Zusammenfassung

A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

detaillierte Beschreibung

In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Gesamtstatus Unknown status
Anfangsdatum February 2017
Fertigstellungstermin April 2018
Primäres Abschlussdatum February 2018
Phase Phase 1/Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
ESSDAI improvement week 24
ESSPRI improvement week 24
Sekundäres Ergebnis
Messen Zeitfenster
Unstimulated salivary flow rate week 24
Schimer's test week 24
SF-36 week 24
HAQ week 24
Immunoglobulins week 24
Rheumatoid Factors week 24
Einschreibung 30
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Iguratimod

Beschreibung: Iguratimod 25 mg orally twice a day for 24 weeks

Armgruppenetikett: Iguratimod

Anderer Name: T-614

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria

- Positive dry eyes and (or) dry mouth symptoms

- Hyperglobulinemia

Exclusion Criteria:

- Complicated with other systemic autoimmune diseases

- Severe complications of Sjogren's syndrome

- Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit

- Active infections or chronic infectious diseases

- A history of malignancies

- Pregnancy or breathfeeding

- Inability to comply with the study protocol for any other reason

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Yan Zhao, Dr. Principal Investigator Peking Union Medical College Hospital
Gesamtkontakt

Nachname: Hua Chen, Dr.

Telefon: 86-10-69158797

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler: Peking Union Medical College Hospital Hua Chen, Dr. 86-10-69158797 [email protected] Yan Zhao, Dr. Principal Investigator
Standort Länder

China

Überprüfungsdatum

January 2017

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Iguratimod

Art: Experimental

Beschreibung: Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.

Patientendaten No
Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov